Infirmier(ère) autorisé(e) en essais cliniques - Registered Nurse - Rimouski

Bayshore•Quebec, QC

2d•Hybrid

About The Position

The Specialty Pharma Nurse, Clinical Trials Registered Nurse (CTRN) reports directly to the Specialty Pharma Nurse Supervisor (SPNS) and/or Specialty Pharma Nurse Manager (SPNM). In this role, the CTRN works in close collaboration with the Scientific Affairs (SCA) team to deliver and monitor specialized infusion, injectable or oral pharmacological treatments, investigational medicinal products in the home and/or clinic setting. The CTRN administers protocol-specific nursing care to participants in home, clinic, or community settings within decentralized or hybrid trials. This position upholds patient care standards, ensures strict protocol and regulatory compliance, and serves as the primary liaison for the sponsor and study team in the participant’s environment. The CTRN is responsible for monitoring the patient for clinical trial study related reactions (intervening as required or directed by protocol), accurately documenting the procedure on electronic charts or clinical trial source documentation and submitting reporting in a timely manner. The CTRN is expected to maintain effective communication with the SPNS and/or SPNM along with the Scientific Affairs Team to ensure patient safety and satisfaction. Specialized pharmacological or clinical trial training will be provided. This role offers the opportunity to specialize in clinical trial support and actively contribute to clinical research initiatives. Bayshore has a focus on nursing education and provides many opportunities for nurses to advance their professional growth. A minimum commitment of two days per week, Monday through Friday, is required. Bayshore will work with you to assemble a working schedule that fits your lifestyle. CTRN is a one-on-one patient experience, and we strive to ensure that patients stay with the same nurse to ensure the best quality and continuity of care.

Requirements

Registered Nurse (RN) designation.
Minimum of two days per week availability, Monday through Friday.
Specialized pharmacological or clinical trial training will be provided.

Nice To Haves

Experience in clinical trial support.
Experience in specialized nursing procedures.
Experience with IV access (peripheral IV initiation or central line access).

Responsibilities

Follow all training mandated by clinical trial protocols and regulations, including extensive theoretical instructions.
Ensure compliance with Good Clinical Practice (GCP), International Counsel of Harmonization (ICH) guidelines, Standard Operation Procedure (SOPs,) and local regulatory requirements.
Develop and review nursing care plans that are individualized to each patient.
Conduct patient health assessments and medication administration teaching.
Demonstrate competency in phlebotomy including venipuncture across diverse patient populations.
Perform lab sample processing, packaging, centrifuge operation and shipment in accordance with protocol, dangerous goods and sponsor requirements.
Coordinate and manage courier services for biological sample collection, study medication deliveries, and study supplies in accordance with protocols and temperature requirements.
Obtain IV access through peripheral IV initiation or central line access (PICC, IVAD, etc.) from patients of all ages.
Prepare and administer a variety of specialized or investigational medicinal product intravenous or injectable pharmacological treatments from patients of all ages, per protocol.
Conduct other protocol assessments including but not limited to ECGs, Spirometry, limited physical assessments, electronic patient reported outcomes (EPROs).
Provide patient care by utilizing the skills of observation, assessment, nursing diagnosis, counseling, health teaching, and reporting any adverse events to immediate supervisor or required stakeholders.
Perform routine nursing duties in accordance with company policies and procedures, and provincial body standards.
Ensure accurate, timely and protocol-compliant documentation to support data integrity and contractual obligations.
Provide patient centered care according to the established care plan or medical directive.
Perform specialized nursing procedures for which recognized training and current competencies have been demonstrated and updated per standards.
Maintain role related training and updates as required.
Observe and document patient conditions.
Report and document Adverse Events as per Pharmacovigilance requirements.
Complete all other duties as requested.